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Showard Law Firm holds drug manufacturers responsible for their negligent actions. When pharmaceutical companies put profits over consumer safety, victims deserve justice and fair compensation. Peer-reviewed literature suggests that manufacturers of gadolinium-based contrast agents (GBCAs) may have had knowledge of the serious risks of MRI gadolinium-toxicity decades ago but failed to warn healthcare professionals and the public.
Plaintiffs share similar allegations in recent gadolinium lawsuits, claiming that GBCAs remain in the body, putting patients at increased risk for debilitating side effects and Gadolinium Deposition Disease. Litigation against makers of gadolinium-based contrast agents contends that the defendants, through their omissions and misrepresentation, concealed the inherent short and long-term risks of gadolinium.
Showard Law Firm is well-versed in Gadolinium lawsuit liability issues pertaining to contrast dye retention and provides vigorous advocacy for those who have been harmed. If you or a loved one is experiencing unexplained symptoms after an MRI scan with gadolinium, we encourage you to reach out for a private case review, free of charge.
Gadolinium lawsuit liability – potential causes of action
If it can be proven that manufacturers of compounds like Magnevist, Omniscan and other Gadolinium contrast agents knew or should have known about the adverse effects of gadolinium retention, plaintiffs may be eligible for significant damages based on theories of product liability. The entities that designed, manufactured, distributed, or furnished the contrast agent may be held liable under the following causes of action:
- Negligence – Failure to exercise reasonable care
- Design Defect – the product’s faulty design made it unreasonably dangerous
- Failure to Warn – failing to provide adequate warnings, instructions or labels with the product
- Breach of Express and Implied Warranties
Gadolinium contrast agents approved by the FDA include:
- Dotarem (gadoterate meglumine) manufactured by Guerbet LLC
- MultiHance (gadobenate dimeglumine) manufactured by Bracco Diagnostics Inc.
- Eovist (gadoxetate disodium) manufactured by Bayer Healthcare Pharmaceuticals
- Omniscan (gadodiamide) manufactured by GE Healthcare
- Gadavist (gadobutrol) manufactured by Bayer Healthcare Pharmaceuticals
- Magnevist (gadopentetate dimeglumine) manufactured by Bayer Healthcare Pharmaceuticals
- ProHance (gadoteridol) manufactured by Bracco Diagnostics Inc.
- OptiMARK (gadoversetamide) manufactured by Guerbet/LiebelFlarsheim Company LLC
Studies and reports on Gadolinium deposition
Gadolinium-based contrast agents have been utilized to enhance the quality of MRI’s since the mid- 1980’s, and by some estimates are administered in up to half of all Magnetic Resonance Imaging studies. GBCA’s are said to have a half-life of 90-120 minutes in individuals with healthy renal function, but many patients have found this estimate to be misleading.
Several studies and reports suggest that patients are not always left with harmless trace amounts of the contrast agent following an MRI, and that gadolinium can be stored in bodily tissues for extended periods of time.
What clinical effects do deposits of gadolinium have on the human body? According to the FDA Adverse Event Reporting System (FAERS), symptoms can range from cognitive impairments and burning sensations to skin and musculoskeletal problems.
Medical literature on gadolinium retention and general risks may increase manufacturer liability in the court systems.
- 1989 – intracerebral masses seen on enhanced MRI images 8 days after injection of Magnevist, with later tests revealing high levels of gadolinium in the tissue
- 2011 — study shows connection between gadolinium and neural cell death
- 2016 – deposits of gadolinium discovered in brains and bones of people with normal kidney function
- 2016 – National Institutes of Health reports on Gadolinium deposition in the brain
- 2016 – The term ‘Gadolinium Deposition Disease’ is coined by Dr. Richard Semelka based on landmark study “Gadolinium in Humans: A Family of Disorders”
Gadolinium litigation history
In earlier litigation concerning gadolinium side effects, plaintiffs have prevailed in their allegations that manufacturers failed to caution about the risk of nephrogenic system fibrosis (NSF) in people with kidney impairment or renal failure.
Manufacturers such as GE Healthcare have settled dozens of lawsuits involving nephrogenic system fibrosis out of court, brought by patients seeking monetary compensation for their life-altering injuries.
Emerging litigation focuses on Gadolinium Deposition Disease and whether manufacturers breached their duty to design, manufacture and promote a safe product. The United States Judicial Panel on Multidistrict litigation recently denied the request to consolidate cases before a single judge for streamlined proceedings. This decision was rendered when the JPML found that the injuries alleged in each claim appeared to be highly plaintiff-specific, thus precluding centralization.
However, as more lawsuits are brought in courtrooms across the country, the JPML may re-consider a new petition for gadolinium multidistrict litigation.
FDA actions concerning GBCAs
The FDA has taken the following actions regarding gadolinium-based contrast agents:
- 2015 — Drug safety communication alerts medical professionals and patients that the agency is investigating the risk of gadolinium deposits in the brain after repeated MRIs
- 2017 – Medical Imaging Drug Advisory Committee suggests implementing a warning about gadolinium retention following MRI studies with GBCAs
- 2017 – Drug Safety communication issued stating that GBCAs are retained in the body. The FDA demands label changes and additional studies.
- 2018 – In addition to approving the updated prescribing information concerning the gadolinium retention risks, the FDA mandates new patient Medication Guides for all GBCAs.
The new class warning reads “Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone.”
Evaluate your legal options
Gadolinium retention can lead to serious medical conditions that can undermine the quality of your life. To discuss gadolinium lawsuit liability issues and the merits of your case with experienced product liability attorneys, call Showard Law Firm today.
Additional Resources on Gadolinium Lawsuit Liability Issues:
- JAMA, Gadolinium Retention After Contrast-Enhanced MRI https://jamanetwork.com/journals/jama/fullarticle/2702593
- LightHouse Project, Gadolinium Toxicity https://gadoliniumtoxicity.com/
- US JPML, LINEAR GADOLINIUM-BASED CONTRAST AGENTS PRODUCTS LIABILITY LITIGATION http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2868-Denied-Transfer-09-18.pdf
- FDA, FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI) https://www.fda.gov/Drugs/DrugSafety/ucm455386.htm
- FDA, FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
- Radiology Solutions, Important Drug Warning for All Gadolinium-Based Contrast Agents https://www.radiologysolutions.bayer.com/static/media/PDFs/Gadolinium_Info.pdf